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Completed

NCT Number: NCT00441870

Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

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Key information

Conditions

Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Greenebaum Cancer Center - University of Maryland Medicine, Baltimore, Maryland, United States

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About this study

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Histological or cytological diagnosis of neoplasm
  • No effective standard therapeutic options
  • ECOG performance status of 0-2
  • ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
  • Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
  • Adequate bone marrow reserve, renal and hepatic function

Exclusion criteria

  • Concurrent malignancies
  • Women who are pregnant or lactating
  • Evidence of symptomatic brain metastases
  • Receiving concomitant anticancer therapy (excluding supportive care)
  • Requires palliative radiotherapy at time of study entry
  • Unable to tolerate conditions for radionuclide imaging
  • Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20

Treatment and study plan

EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)

Drug

Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)

Other names: Folic acid desacetylvinblastine hydrazide conjugate

99mTC-EC20 (Folic acid-technetium 99m conjugate)

Drug

20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging

Other names: Folic acid-technetium 99m conjugate, FolateScan

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients

Secondary outcomes

  1. Pharmacokinetic and pharmacodynamic parameters

    Time frame: Obtained during the first cycle of therapy on Days 1 and 3

  2. Anti-tumor activity

    Time frame: Initial dose of study therapy to disease progression

  3. Uptake of 99mTc-Ec20 in tumors and normal tissues

    Time frame: 1-2 hours post-administration of 99mTc-EC20

  4. Safety and tolerability

    Time frame: Initiation of study therapy through 30 day post last dose of study therapy

Sponsors and collaborators

Lead sponsor

Endocyte

Industry

Registry information

Official study title

Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 1, 2007
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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